NCT03010995

The Acute Cardiovascular Effects of Nicotine in E-cigarettes (ACE) Study

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The goal of this project is to evaluate the nicotine induced acute cardiovascular changes in E-Cigarette users and also study the mechanism involved particularly with vascular impairment.

Detailed description

We will recruit 30 experienced E-cigarette users (those using E-Cigarette for at least 1 month and ≤ 1 tobacco cigarette / day), between ages 21-40 years; in 4 day study visit and 10 non-smokers (those who used less than 100 tobacco cigarettes in their lifetime and not active nicotine/tobacco or related product user) for a one study visit.The participants will be asked to abstain from all tobacco/nicotine and related product use for 12 hours before each visit. Measurements will be taken at each study visit before and after E-cigarette use, each day with different nicotine dose, to look at both the individuals' exposure to nicotine and also the effects on the cardiovascular system. These measurements will include blood and urine samples as well as non-invasive cardiovascular measurements.

Conditions

• Cigarette Smoking Toxicity
• Nicotine
• Acute Cardiovascular Disease

Interventions

Type	Name	Description
DRUG	Prazosin	Prazosin will used to study the mechanism involved in nicotine induced acute cardiovascular changes

Timeline

• Start date: 2018-03-13
• Primary completion: 2018-07-24
• Completion: 2018-07-24
• First posted: 2017-01-05
• Last updated: 2018-07-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study